Study to Compare the Effect of Ropinirole Prolonged Release Once-daily Versus Twice-daily
An Open-label, Multi-center, Crossover Study to Compare the Effect of Once-daily Ropinirole PR and Twice-daily Ropinirole PR in Patients With Parkinson Disease
1 other identifier
interventional
82
1 country
2
Brief Summary
- 1.In order to compare the benefit, side effects, and patient preference of Ropinirole prolonged release when used in once-daily or twice-daily dosing
- 2.In order to estimate the conversion rate of dopamine agonists into Ropinirole prolonged release
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 parkinson-disease
Started Sep 2009
Shorter than P25 for phase_4 parkinson-disease
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 24, 2009
CompletedFirst Posted
Study publicly available on registry
September 29, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedResults Posted
Study results publicly available
September 9, 2013
CompletedSeptember 9, 2013
September 1, 2013
1.2 years
September 24, 2009
July 7, 2012
September 4, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Patient Preference
Patient preference between once-daily and twice-daily regimen
After 16 weeks or at last visit for early completion
Secondary Outcomes (13)
Unified Parkinson's Disease Rating Scale, Part 3
8 weeks for each arm or at last visit
Hoehn and Yahr Stage
8 weeks for each arm or at last visit
Overall Quality of Sleep
8 weeks for each arm or at last visit
Nocturnal Off-symptoms
8 weeks for each arm or at last visit
Early Morning Off Symptoms
8 weeks for each arm or at last visit
- +8 more secondary outcomes
Study Arms (2)
Ropinirole PR QD first, then BID
ACTIVE COMPARATORGive Roipinirole prolonged release (PR) once-daily (QD) dose first, then twice-daily (BID) dosing
Ropinirole PR BID first, and then QD
ACTIVE COMPARATORGive Ropinirole prolonged release (PR) twice-daily (BID) dosing, and then once-daily (QD) dosing
Interventions
Change Ropinirole immediate release or Pramipexole immediate release to Ropinirole prolonged release (PR) once-daily or twice-daily
Eligibility Criteria
You may qualify if:
- Age: 30-80
- Parkinson disease
- On dopamine agonists (Ropinirole IR or Pramipexole IR) and are considering to change into Ropinirole PR
- On stable antiparkinsonian medication for at least 4 weeks
- Who signed consent to the study
You may not qualify if:
- Who are on less than 2 mg of Ropinirole IR or 0.375 mg of Pramipexole IR
- Who have dementia, psychosis, major depression and other serious neurological or medical problems
- Who are allergic to the similar medications
- Who has history of heavy metal poisoning
- Who were on othe clinical trials of other medications within the last 4 weeks
- Whoa re pregnant or lactating
- Who are considered not eligible by the investigator
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Seoul National University Hospital
Seoul, 110-744, South Korea
Boramae City Hospital
Seoul, South Korea
Related Publications (3)
Lyons KE, Pahwa R. An open-label conversion study of pramipexole to ropinirole prolonged release in Parkinson's disease. Mov Disord. 2009 Oct 30;24(14):2121-7. doi: 10.1002/mds.22750.
PMID: 19768728BACKGROUNDStocchi F, Hersh BP, Scott BL, Nausieda PA, Giorgi L; Ease-PD Monotherapy Study Investigators. Ropinirole 24-hour prolonged release and ropinirole immediate release in early Parkinson's disease: a randomized, double-blind, non-inferiority crossover study. Curr Med Res Opin. 2008 Oct;24(10):2883-95. doi: 10.1185/03007990802387130. Epub 2008 Sep 2.
PMID: 18768106BACKGROUNDYun JY, Kim HJ, Lee JY, Kim YE, Kim JS, Kim JM, Jeon BS. Comparison of once-daily versus twice-daily combination of ropinirole prolonged release in Parkinson's disease. BMC Neurol. 2013 Sep 2;13:113. doi: 10.1186/1471-2377-13-113.
PMID: 24004540DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
This study was designed to open-label study. We cannot exclude the psychological effect of each regimen.
Results Point of Contact
- Title
- BS Jeon
- Organization
- Seoul National University Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Beom S Jeon, MD, PhD
Seoul National University Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 24, 2009
First Posted
September 29, 2009
Study Start
September 1, 2009
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
September 9, 2013
Results First Posted
September 9, 2013
Record last verified: 2013-09